MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY CO. HEMOSIL HIT- AB(PF4-H); PLATELET FACTOR 4 RADIOIMMUNOASSAY

Catalog Number	0020014600
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported two complaints regarding a negative result for hit-ab run on two separate acl top 700 instruments.A separate report (1217183-2024-00002) has been filed for the sample analyzed on acl top 700 serial number (b)(6).It was reported that a patient suspected of hit received a negative result on the acl top 700 serial number (b)(6).Other methods of testing (elisa and sra) were positive.The customer considers the negative result from the acl top 700 erroneous.The negative result from the acl top 700 was not reported, as the positive elisa test fit the patient's profile.No corrected report was issued and there was no impact to the patient.
Additional Manufacturer Narrative
This is an initial report.Investigation is ongoing.The reportability is based on the assessment that treatment could have changed based on the negative result and potentially caused harm.
Additional Manufacturer Narrative
A complaint was submitted on hemosil hit-ab (pf4-h) pn 00020014600 lot b36074 indicating that a false negative result was generated by acl top 700 sn (b)(6).Sample id (b)(6) was run (b)(6) 2024 13:39:48 and produced a hit-ab result of 0.0 u/ml.The sample was repeated on another acl top instrument and produced a negative result.The patient was suspected of hit; therefore, elisa testing was performed and yielded a positive result.No corrected report was issued as only the positive result was released to the chart.There was no patient impact.Review of the submitted data identified the samples that the customer reported.The instrument was performing to specifications during sample analysis as indicated in the instructions for use.Manufacturing and qc data from hemosil hit-ab (pf4-h) lot b36074 was reviewed.Neither issues nor trends were identified with the impacted lot.According to the results reviewed, no deficiency is identified for hemosil hit-ab (pf4-h) lot b36074.Based on the above, there was no indication of an instrument malfunction or deficiency of the reagent.No remedial action is required.

• Brand Name: HEMOSIL HIT- AB(PF4-H)
• Common Device Name: PLATELET FACTOR 4 RADIOIMMUNOASSAY
• Manufacturer (Section D): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY CO.; 180 hartwell road; bedford MA 01730
• Manufacturer Contact: anuja khan ; 180 hartwell road; bedford, MA 01730
• MDR Report Key: 19175720
• Report Number: 1217183-2024-00003
• Device Sequence Number: 6500027
• Product Code: LCO
• UDI-Device Identifier: 08426950975380
• UDI-Public: 08426950975380
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K153137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: 0020014600
• Device Lot Number: B36074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown